Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation
Primary Purpose
Stable Angina
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Diltiazem treated group
Bisoprolol treated group
Candesartan treated group
Sponsored by
About this trial
This is an interventional treatment trial for Stable Angina
Eligibility Criteria
Inclusion Criteria:
- Stable angina patients whose coronary lesions is confirmed by angiography or receives PCI
- Unstable Angina/NSTEMI patients who completed PCI for main lesions
- Either systolic > 130mmHg or diastolic > 80mmHg, or patients with anti-hypertensive drugs
Exclusion Criteria:
- STEMI patients within one month
- Variant Angina
- Liver function abnormality or renal failure
- History of Hypersensitivity to testing drugs
- Severe heart failure(NYHA class>3) or uncorrectable hematologic disease
- Woman possible to be pregnant
- Uncontrolled diabetes
- Expected life span < one year
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Diltiazem treated group
Bisoprolol treated group
Candesartan treated group
Arm Description
Diltiazem 180mg treated group
Bisoprolol 5mg treated group
Candesartan 32mg treated group
Outcomes
Primary Outcome Measures
Wall to lumen ratio of fundus vessel
Measurement of change in the ratio of wall thickness to lumen of the fundus vessel from baseline to 9 month follow up
Secondary Outcome Measures
lipid parameter
Measurement of change in total cholesterol, triglyceride, LDL, small dense LDL, and HDL
Serum markers of inflammation
CRP
Change of nitrate need
Measure of change of nitrate need
Full Information
NCT ID
NCT01162902
First Posted
April 30, 2010
Last Updated
December 15, 2013
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01162902
Brief Title
Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation
Official Title
Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Treatments for stable angina includes drug therapy such as calcium-channel blocker, beta blocker, and ACEI/ARB. To obtain good prognosis in patients with coronary artery disease,preventing or correcting the progression of atherosclerosis and dyslipidemia is more important than relieving angina symptom. Dysfunction of microvessel is one of the most important factor in patients with coronary artery disease. Recently, we developed the new non-invasive method of evaluating the microvessel in fundus. With this methods, we will compare the effect of each drug (beta blocker, CCB, ARB).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Angina
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diltiazem treated group
Arm Type
Experimental
Arm Description
Diltiazem 180mg treated group
Arm Title
Bisoprolol treated group
Arm Type
Active Comparator
Arm Description
Bisoprolol 5mg treated group
Arm Title
Candesartan treated group
Arm Type
Active Comparator
Arm Description
Candesartan 32mg treated group
Intervention Type
Drug
Intervention Name(s)
Diltiazem treated group
Intervention Description
Diltiazem 180mg for 9 months
Intervention Type
Drug
Intervention Name(s)
Bisoprolol treated group
Intervention Description
Bisoprolol 5mg for 9 months
Intervention Type
Drug
Intervention Name(s)
Candesartan treated group
Intervention Description
Candesartan 32mg for 9 months
Primary Outcome Measure Information:
Title
Wall to lumen ratio of fundus vessel
Description
Measurement of change in the ratio of wall thickness to lumen of the fundus vessel from baseline to 9 month follow up
Time Frame
baseline, 9 months
Secondary Outcome Measure Information:
Title
lipid parameter
Description
Measurement of change in total cholesterol, triglyceride, LDL, small dense LDL, and HDL
Time Frame
baseline, 9 months
Title
Serum markers of inflammation
Description
CRP
Time Frame
baseline, 9 months
Title
Change of nitrate need
Description
Measure of change of nitrate need
Time Frame
baseline, 1 months, and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stable angina patients whose coronary lesions is confirmed by angiography or receives PCI
Unstable Angina/NSTEMI patients who completed PCI for main lesions
Either systolic > 130mmHg or diastolic > 80mmHg, or patients with anti-hypertensive drugs
Exclusion Criteria:
STEMI patients within one month
Variant Angina
Liver function abnormality or renal failure
History of Hypersensitivity to testing drugs
Severe heart failure(NYHA class>3) or uncorrectable hematologic disease
Woman possible to be pregnant
Uncontrolled diabetes
Expected life span < one year
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hae-Young Lee, MD, PhD
Phone
82-10-4528-6160
Email
hylee612@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Hyo-Soo Kim, MD, PhD
Phone
82-2-2072-2226
Email
hyosoo@snu.ac.kr
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyo-Soo Kim, MD, PhD
First Name & Middle Initial & Last Name & Degree
Hae-Young Lee, MD,PhD
12. IPD Sharing Statement
Learn more about this trial
Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation
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